December 9, 2013 – The paper recognized in the IMIA yearbook highlights the methodology they used to make the ClinicalTrials.gov data easier to analyze.
The editorial board for the 2013 International Medical Informatics Association (IMIA) yearbook recently named a DCRI analysis of ClinicalTrials.gov as one of the best medical informatics papers of 2012.
Asba Tasneem, PhD, was the lead author for the paper, “The database for aggregate analysis of ClinicalTrials.gov and subsequent regrouping by clinical specialty.” The DCRI’s Laura Aberle, Hari Ananth, Swati Chakraborty, Karen Chiswell, PhD, Brian McCourt, and Ricardo Pietrobon, MD, were co-authors.
ClinicalTrials.gov was originally designed as a resource for researchers, patients, and patient advocates to help them find trials of interest that were enrolling patients or seeking to add more sites. Since it was created, the registry has grown into a repository with information on more than 153,000 clinical trials from around the world. Despite the significant amount of data, it was not in a format that could be easily used in analyses.
The researchers aggregated the data from the registry,created 18 different specialty data sets that were further subdivided into specific diseases (for example, endocrinology would include thyroid conditions and diabetes), and then developed a downloadable Oracle database that makes it simpler to study specific types of trials. The paper recognized in the IMIA yearbook highlights the methodology they used to make the ClinicalTrials.gov data easier to analyze.
The tool they developed has already been used as the basis for more in-depth analyses. For example, Califf used the tool to compare government funding versus industry funding for cardiology, oncology, and mental health trials.
During the creation of the tool, the DCRI team found discrepancies between data that researchers are legally required to submit about their trials and what was actually uploaded to the registry. Because ClinicalTrials.gov does not mandate completion of many fields that are legally required in order to register a trial, the DCRI researchers found gaps in information across specialties. For example, many trials did not include information on data monitoring committees, even though trials likely used them.
“The work we did with ClinicalTrials.gov to create this tool was interesting and complex, and hopefully it will have an impact for years to come on how people use the data,” said Tasneem. “I feel very fortunate to have been part of such an exciting project.”
This work is part of the Clinical Trials Transformation Initiative’s State of Clinical Trials project. The paper, The Database for Aggregate Analysis of ClinicalTrials.gov(AACT) and Subsequent Regrouping by Clinical Specialty, was published in PLOS One in May 2012. A link to the paper and other publications using the AACT database are available on the CTTI website.